As you know, pharmaceutical industry is a regulated industry and makes products that directly affect the health of the patient. Because all these pharmaceutical products are administered by the patient, then the safety of the products becomes very important.

So now the question is how can we do regular watch, so the answer is a regular management review meeting.

“Better the Management Review, Better the performance of organization will be.”

Regulatory view on Management review

ICHQ10 

Management Review (2.6)
(a) Senior management should be responsible for pharmaceutical quality system governance through management review to ensure its continuing suitability and effectiveness.

(b) Management should assess the conclusion of periodic review of process performance and product quality and of the pharmaceutical quality system, as describe in section IV (3) and V (4). 

Eudralex EU-GMP Vol. IV guide to GMP Chapter-1 section 1.6

There should be a periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement of products, processes and the system itself.

21 CFR 820.20 Management responsibility
Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.

Management review meeting should be attended by leadership team and representative to decide the action and agreed action plan. Site should have a procedure on management review and procedure should have clear responsibility, agenda & points need discussion and defined frequency for management review. Well articulated agenda for management review is very much required by considering the following points but not limited to;

Agenda of discussion for Management Review in pharmaceutical industry

Following key element should be included in the agenda of management review for discussion and effective implementation of all these element. Any hurdle in implementation should be escalate to decide further action plan.

  1. Update on the previous meeting action
  2. Quality objective review (organization should have quality KPI and routinely review, more frequent review then management review meeting)
  3. Customer complaints
  4. Change control
  5. Deviation
  6. Out of Specification
  7. Out of trends
  8. Validation & Qualification status
  9. Supplier review
  10. Product Quality Review
  11. Risk Management
  12. Training
  13. Documentation
  14. Stability review
  15. Environmental monitoring & water analysis review
  16. Any regulatory update/ change in legislation requirement
  17. Self inspection / internal audit
  18. External audit CAPA progress (if any)
  19. Any other business

It also depends on what parameters you focus on and how to use data analytics during management review. Just focusing on the parameters and using data analytics is not enough, it is also necessary to identify the gaps within the system and process and to perform time-bound actions, and check the progress regularly to make management review more effective and efficient.

Now, let’s know which parameters should be included in the management review?

How management review element should evaluate in management review meeting?

Under each management review element – what should be reviewed , refer below image … All these element should be represent with some kind of graphical representation for better understanding and in a focus way…

Picture-Management Review Element
Picture-Management Review Element

Apart from all key point define in above image, there are some other element in agenda for discussion which required some kind of review as detailed below;

Training

Training progress should be reviewed and present with following key points but not limited to;

  • Training compliance against agreed training calendar/ schedule.
  • Department-wise training compliance
  • GMP training completion
  • Any hurdle in completion of agreed training / solution

Documentation

Documentation process should be reviewed and present with following key points but not limited to;

  • Any repetitive good documentation practices error
  • Identify the requirement of training on good documentation practices procedure
  • Root cause of repetitive good documentation practices error
  • Opportunity to reduce the complexity in document/ procedure

Stability Review

In this section we can review any significant change in the current product stability and its impact on the existing commercial product or on new launch and accordingly decide further actions.

EMP & Water analysis Review

In this section we can discuss any unusual trends of microbial count or identification of any new strain/ objectionable organism.

Regulatory update

As pharmaceutical is a regulated industry and there are frequent change happened in regulatory norm / legislation so keep an eagle’s eye on all those changes and should be discussed in the meeting to decide further implementation plan.

Self-Inspection/ Internal audit

Following points should be discussed around self-inspection / internal audit but not limited to;

  • Adherence to self-inspection schedule
  • Any outstanding action
  • Critical / Major observation
  • Previous agreed action progress/ hurdle in implementation.

External Audit

Following points should be discussed under external audits but not limited to;

  • Any forthcoming regulatory audits
  • Previous audit CAPA progress & implementation
  • Escalation of any outstanding agreed action

Apart from all above elements, any other related to business can be discuss during management review to decide further action plan and track the progress for continual improvement of pharmaceutical quality system.

A minute of meeting should be prepared and get it signed from all attendee for their alignment on the agreed action as it is define in the GMP, “If you have not documented any activity, you have not done that activity”

KEY NOTES

  1. Site should have management review procedure with detailed agenda of discussion, responsibilities, frequency and schedule.
  2. Meeting invite should be send in advance with agenda to all leadership team/ other member.
  3. Update/ progress on previous meeting should be discuss and align target timeline if any previously agreed action not completed within timeline or if extra time is required to complete previously agreed task
  4. Represent each management review element in a graphical manner with focus area.
  5. Last but not least – minutes of meeting should be prepared & signed with all attendee with previous action update, new action identified in meeting with target timeline and responsibility.

I hope you liked article, you can share your experience through your comments.